NCT01937819

Brief Summary

High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of bowel preparation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

September 4, 2013

Last Update Submit

September 4, 2013

Conditions

BOWEL PREPARATION (BOWEL CLEANSING)

Keywords

BOWEL PREPARATIONSMARTPHONE APPLICATION

Outcome Measures

Primary Outcomes (1)

  • bowel cleaning quality according to Ottawa scale scores

    3 months

Secondary Outcomes (1)

  • The consistency of bowel cleansing result by SMARTPHONE application with Ottawa scale scores by colonoscopy

    3 months

Study Arms (2)

SMART arm

EXPERIMENTAL

Using SMARTPHONE application for self judging bowel preparation

Device: SMART arm

Conventional arm

NO INTERVENTION

Non-using SMARTPHONE application for bowel preparation

Interventions

SMART armDEVICE

The SMARTPHONE application for self judging bowel preparation by taking the picture of stool form.

Also known as: SMART-BP
SMART arm

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera

You may not qualify if:

  • known or suspected bowel obstruction known pregnancy, breast feeding known allergy to PEG presence of severe illness(renal failure, congestive heart failure, liver failure,), refusal of consent to participate in the study not available to use the SMARTPHONE application and SMARTPHONE camera

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

Central Study Contacts

Jongha Park, M.D.

CONTACT

+82-51-797-0200neakker@gmail.com

Gijung Jeon, M.D.

CONTACT

+82-51-797-0200elecyx@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study principal investigator

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 10, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

KR(1)